Flumethasone Pivalate API Manufacturer in India

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Flumethasone Pivalate API

Flumethasone Pivalate is a synthetic fluorinated corticosteroid ester with glucocorticoid, anti-inflammatory and antipruritic activity. It is also known as Flumetasone Pivalate and Flumethasone 21-Pivalate. The compound has CAS Number 2002-29-1, molecular formula C₂₇H₃₆F₂O₆, and molecular weight 494.57 g/mol.

Flumethasone Pivalate is a difluorinated corticosteroid ester used primarily in topical pharmaceutical preparations. It provides anti-inflammatory, antipruritic and vasoconstrictive effects at the site of application.

Key Features

  • Product Name: Flumethasone Pivalate
  • CAS Number: 2002-29-1
  • Molecular Formula: C₂₇H₃₆F₂O₆
  • Molecular Weight: 494.57 g/mol
  • Chemical Class: Fluorinated Corticosteroid
  • Pharmacological Class: Glucocorticoid
  • Therapeutic Class: Topical Corticosteroid
  • UNII: 0DV09X6F21
  • PubChem CID: 443980
  • EC Number: 217-901-1
  • Physical Form: Solid 

Chemical Identity

IUPAC Name:
[2-[(6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-difluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] 2,2-dimethylpropanoate.

Pharmaceutical Application

Flumethasone Pivalate is used in topical corticosteroid preparations for inflammatory and pruritic dermatological conditions. Its corticosteroid activity helps reduce inflammation, exudation and itching.

Mechanism of Action

Flumethasone Pivalate acts through glucocorticoid receptors. Topical corticosteroid activity suppresses inflammatory processes and reduces associated skin inflammation and itching.

Physicochemical Characteristics

PubChem reports Flumethasone Pivalate as a solid with a calculated molecular weight of 494.6 g/mol. An experimental melting point of approximately 219°C is reported for the base compound, while commercial analytical data report optical rotation under specified conditions.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0%–103.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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